The U.S. Food and Drug Administration (FDA) has issued a safety communication noting the potential need for early device replacement of Boston Scientific Corporation Accolade pacemaker devices.

Impacted devices include the Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers, as well as the Visionist and Valitude CRT pacemakers.

Boston Scientific has also issued a recall for a subset of Accolade pacemaker devices, which may permanently enter into a safety mode that can inhibit the device’s ability to regulate heart rhythm.

Access the FDA website for more information.